Title: Chemical Synthesis Facility
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 75N94022R00001
- Agency
- National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Child Health and Human Development seeks proposals to provide a Chemical Synthesis Facility to synthesize and purify drug substances under current Good Manufacturing Practice standards for clinical trials conducted by the Contraceptive Clinical Trials Network in support of the Contraceptive Development Program's research and development efforts. Offerors must demonstrate the capability to synthesize a minimum of 10-24 and maximum of 48 small molecules per year at over 95% purity as well as a minimum of one and maximum of two cGMP lots per year at over 99% purity. Proposals are due by June 23, 2022 and will be evaluated based on technical approach, past performance, and price.
There is no set-aside designation for this full and open competition under NAICS code 541715. The incumbent contractor is required to synthesize new chemical entities not commercially available for use in contraceptive drug and device evaluation. Offerors must provide cost estimates for a minimum effort of $2 million and maximum of $4 million annually over a one year base period and five one-year options. The place of performance will be at the contractor's facility for the period of September 2022 through September 2028.
Notice text
The Contraceptive Development Program (CDP) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is issuing this Request for Proposals (RFP) for the recompetition of the Chemical Synthesis Facility (CSF) contract. The RFP is a full and open competitive procurement under the North American Industry Classification Systems Code 541715. The CDP supports research and research training programs in contraceptive discovery and development. Major research areas include (1) studies of mechanisms of action and effects of approved contraceptive methods and reproductive hormones, (2) evaluation of novel methods under development (drugs, devices, and procedures), and (3) development and evaluation of optimal formulations and dosages of contraceptive agents and devices. The main goal of the CSF is the cGMP manufacture of drug substances for clinical trials conducted by the Contraceptive Clinical Trials Network (CCTN).
The mission of the CDP is to provide new and/or improved safe and effective contraceptive methods necessitates making scientific progress. Many of the compounds evaluated by the CDP are new chemical entities (NCEs) and are not available commercially off the shelf (COTS). Such NCEs must be custom synthesized. The use of a CSF with the ability to make products under cGMP is required and critical for carrying out the mission.
Attachments
| File | Type | Posted |
|---|---|---|
| RFP_75N94022R00001_CSF_Amendment_0002_06-15-2022_0002.pdf | ||
| RFP_75N94022R00001_CSF_Amendment_0001_05-13-2022_0001.pdf | ||
| Sol_75N94022R00001_Amd_0001.pdf | ||
| RFP_75N94022R00001_CSF.pdf | ||
| Sol_75N94022R00001.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Title: Chemical Synthesis Facility | Award Notice | |
| Title: Chemical Synthesis Facility | Solicitation | |
| Title: Chemical Synthesis Facility | Pre-Solicitation | |
| Chemical Synthesis Facility | Pre-Solicitation |
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